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Daptomycin Versus Placebo in Patients With Neutropenia and Fever

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ClinicalTrials.gov Identifier: NCT01216241
Recruitment Status : Terminated (The study has shown futility and the objectives could not be reached without enrolling a very large number of subjects.)
First Posted : October 7, 2010
Results First Posted : April 10, 2014
Last Update Posted : April 10, 2014
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Robert Betts, University of Rochester

Study Description
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Brief Summary:
The purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.

Condition or disease Intervention/treatment Phase
Febrile Neutropenia Drug: Daptomycin Other: Saline Placebo Phase 3

Detailed Description:
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops is higher when daptomycin compared to placebo is added at the same time as anti gram-negative therapy. The five day time point is selected because it is at this point where it is recommended to add antifungal therapy to the treatment regimen if the patient is still febrile.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Single Center, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Daptomycin Versus Placebo in Patients With Neutropenia and Fever.
Study Start Date : April 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Daptomycin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Daptomycin
Daptomycin intravenous 8mg/kg once per day 5-10 days.
 Drug: Daptomycin
8 MG/KG IV
Other Name: Cubicin

Drug: Daptomycin
8 mg/kg once daily
Other Name: Cubicin
Placebo Comparator: Saline Placebo
Saline solution
 Other: Saline Placebo
50 ml normal saline once daily


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Afebrile Neutropenic Subjects [ Time Frame: 5 days ]
    To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients in the above categories who are currently undergoing chemotherapy.
  2. Patients at least 18 of age.
  3. Patient expected to reach an absolute granulocyte count of <100 cells/mm3
  4. Patients who have given written consent because of the above criteria must have at least one temperature of greater or equal to 38.3° or temperatures > 38o on at least two occasions before study drug is administered.

Exclusion Criteria:

  1. Patients with lymphoma or with solid tumor undergoing initial chemotherapy. Their neutropenia is of insufficient duration for adequate test of the value of an anti-gram positive antibiotic.
  2. Patients undergoing auto-transplantation, for the same reason as above.
  3. Patients with evidence of a clinical infection such as presence of a pulmonary infiltrate by x-ray or clinical evidence for the presence of cellulitis.
  4. Patients who have received daptomycin in the two weeks prior to enrollment.
  5. Patients with concomitant use of vancomycin.
  6. Patients with creatinine clearance < 30 ml/min or CPK > 3x normal
  7. Patients with significant hepatic dysfunction, defined as baseline liver function tests > 5x above normal.
  8. Patients with known allergy to daptomycin.
  9. Patients previously in this study.
  10. Women of child bearing age who are either lactating or pregnant (as evidenced by a positive urine pregnancy test or positive serum beta-HCG).
  11. Patients previously enrolled in this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216241


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Cubist Pharmaceuticals LLC
Investigators
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Principal Investigator: Robert F Betts, MD University of Rochester
More Information
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Responsible Party: Robert Betts, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01216241    
Other Study ID Numbers: DAPNEUT
First Posted: October 7, 2010    Key Record Dates
Results First Posted: April 10, 2014
Last Update Posted: April 10, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
 Hematologic Diseases
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents